Patient Safety Analyst & Nominated Signatory
AstraZeneca
San José, Provincia de San José
hace 5 días

At AstraZeneca, we’re not afraid to do things differently. We’re resetting expectations of what a bio-pharmaceutical company can be.

This means we’re opening up new ways to work, pioneering cutting edge methods and bringing unexpected teams together. As Patient Safety Analyst, you will play a key role to support the AstraZeneca CAMCAR Patient Safety Unit in all processes and procedures by ensuring compliance with AstraZeneca requirements and global / local regulatory requirements.

Typical Accountabilities :

  • Support and act as back-up to the functions of the Patient Safety Manager.
  • Support and act as back-up to the functions of the Medical Information Manager.
  • To review and validate AstraZeneca Promotional and non-promotional materials and activities as well as interactions with HCPs and HCPs.

  • Patient Safety functions :
  • Ensures that up-to-date organisation charts, job descriptions, training records and curriculum vitae are available for the local Patient Safety personnel.
  • Responsible for the Case Handling Process of ICSRs and Special Situations (initial safety information and follow-up of ICSRs) in Jasper Platform, including translation of cases from Spanish to English.
  • Materials

  • To review and approve final digital and / or printed version of the Materials, including Internal training materials, against pre-
  • defined, principles-based criteria for approval (eg. in / off label, references, copyright, expiry dates etc).

  • To consult with all relevant teams eg. Brand teams and Marketing, Legal, Compliance, harmacoeconomics and Corporate Affairs, during the development of materials.
  • To monitor materials’ expiry dates.
  • Activities

  • To review and approve Activities requests against pre-defined, principles-based criteria for approval (eg. materials approval, fee and services limits (meals, accommodation and transportation), venue, agenda, participants etc).
  • Fees and Services

  • To review and approve Fees and Services to HCPs against Fair Market Value and / or local limits (eg. annual cap, single pay off etc).
  • HCP travelling

  • To review and approve HCP travelling requests against pre-defined, principles-based criteria for approval (eg. agenda, contract, accommodation etc).
  • Donations

  • To review and approve Donations requests against pre-defined, principles-based criteria for approval.
  • Final review and approval may be through a cross-functional Donations Committee.
  • Sponsorships

  • To review and approve Sponsorships requests against pre-defined, principles-based criteria for approval (eg. invitation, agenda, venue, materials approval etc).
  • Partnerships

  • To review and approve Partnerships requests against pre-defined, principles-based criteria for approval.
  • Advisory Boards

  • To review and approve Advisory Boards requests against pre-defined, principles-based criteria for approval (eg. rationale, materials approval, fees and services limits (meals, accommodation and transportation), venue, agenda, objectives, expected outcomes, participants etc).
  • International HCP Engagements

  • To review and approve International HCP Engagement requests against pre-defined, principles-based criteria for approval (eg.
  • rationale, fees and services limits (meals, accommodation and transportation), venue, agenda, counterpart Nominated Signatory approval etc).

    Brand plans

  • To review and approve Brand Plans against pre-defined, principles-based criteria for approval (eg. correctness of medical / scientific statements, in / off label, references, copyright etc).
  • HCP Classifications or selection

  • To review and approve HCP Classification (eg International KOL, National KOL) or selection requests against pre-defined, principles-
  • based criteria for approval (eg. CV, Publications, Lecturing, Randomized Clinical Trials experience, Academic degree and rank etc).

    Market Research

  • To review and approve Market Research documentation against pre-defined, principles-based criteria for approval (eg. materials checked for hidden promotional messages or disguised non-
  • interventional studies, questionnaires etc).

    Items of Value

  • To review and pre-approve Items of Value against pre-defined, principles-based criteria for approval
  • eg. benefit for HCP’s patients, approval, frequency, cost etc).

  • To include appropriate key learning into training and update materials.
  • Requirements :

  • Good understanding of the Drug Development Process.
  • Good understanding of the Clinical Development Process.
  • Good understanding of the Clinical Study Process.
  • Minimum education requirements :
  • A relevant university degree or equivalent of Pharmacy / Life Sciences / Medical Areas.
  • Knowledge of spoken and written English.
  • Good ability to learn and to adapt to work with IT systems.
  • Other knowledge, skills and abilities
  • Good interpersonal skills.
  • Good intercultural awareness.
  • Excellent organizational skills.
  • Good analytical skills.
  • Good negotiation skills.
  • Excellent communication skills, verbal and written
  • Good presentation skills.
  • NON-NEGOTIABLE CRITERIA :
  • Ability to act fast
  • Procedure following
  • Able to manage discussions
  • Knowledge of spoken and written English (intermediate)

    EQUAL OPPORTUNITIES STATEMENT

    AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-

    assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

    AstraZeneca only employs individuals with the right to work in the country / ies where the role is advertised.

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-

    leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

    We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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